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Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery

Not Applicable
Completed
Conditions
Complication, Postoperative
Cardiac Complication
Interventions
Other: Breath Stacking
Other: Expiratory Positive Airway Pressure
Registration Number
NCT04013360
Lead Sponsor
Universidade Federal de Santa Maria
Brief Summary

This study evaluates the efficacy and safety of a single session of positive expiratory pressure and of breath stacking technique in patients after cardiac surgery. The same patients will receive the two interventions, with an interval of 24 hours, and the acute effect of each will be verifed.

Detailed Description

Physiotherapy uses techniques and equipment that reduce postoperative pulmonary complications. The technique called breath stacking consists of an instrumental feature composed of a unidirectional valve coupled to a face mask to promote the accumulation of successive inspiratory volumes. The technique is used to prevent atelectasis and improve gas exchange. Another therapy is called expiratory positive airway pressure (EPAP) that uses positive end expiratory pressure (PEEP) in spontaneously breathing patients, keeping the airway open during expiration. The EPAP system consists of a face mask, a one-way valve and the expiratory resistor, which is responsible for resistance to expiratory flow, which will determine the level of PEEP.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
Inclusion Criteria

Patients with indication for coronary artery bypass grafting and valve replacement, with surgical procedure for median sternotomy.

Exclusion Criteria
  • incapacity to understand the Informed Consent Form.
  • cognitive dysfunction that prevents the performance of evaluations or interventions,
  • intolerance to the use of EPAP or BS mask
  • with chronic obstructive pulmonary disease (COPD)
  • cerebrovascular disease
  • chronic-degenerative musculoskeletal disease
  • chronic infectious disease
  • in treatment with steroids, hormones or cancer chemotherapy
  • hemodynamic complications (arrhythmia, myocardial infarction during the operation, with blood loss ≥ 20% of the total blood volume, defined by Mannuci, et al., 2007)
  • mean arterial pressure <70 mmHg and reduced cardiac output, requiring the use of intra aortic balloon or vasoactive drugs
  • tracheal intubation for more than 12 hours after admission to the ICU or reintubated
  • individuals unable to maintain airway permeability.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Breath StackingBreath StackingInstrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.
Breath StackingExpiratory Positive Airway PressureInstrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.
Expiratory Positive Airway PressureBreath StackingTherapeutic technique consisting of a face mask, a one-way valve and an expiratory resistor, responsible for resistance to expiratory flow, which will determine the level of pressure in the airway.
Expiratory Positive Airway PressureExpiratory Positive Airway PressureTherapeutic technique consisting of a face mask, a one-way valve and an expiratory resistor, responsible for resistance to expiratory flow, which will determine the level of pressure in the airway.
Primary Outcome Measures
NameTimeMethod
Tidal volume12 to 24 hours after removal of drains and 24 hours after primary intervention

It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period. This measurement will be obtained through the the division of the minute volume by the respiratory rate.

Forced vital capacity (FVC)12 to 24 hours after removal of drains and 24 hours after primary intervention

It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability \<5%) and considered the best curve for the study.

Secondary Outcome Measures
NameTimeMethod
Forced expiratory volume in the first second (FEV1)12 to 24 hours after removal of drains and 24 hours after primary intervention

It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability \<5%) and considered the best curve for the study.

Peak expiratory flow (PEF)12 to 24 hours after removal of drains and 24 hours after primary intervention

It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability \<5%) and considered the best curve for the study.

Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)12 to 24 hours after removal of drains and 24 hours after primary intervention

It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability \<5%) and considered the best curve for the study.

Minute volume12 to 24 hours after removal of drains and 24 hours after primary intervention

It will be evaluated preoperatively and also before and after 10 minutes of each intervention. To obtain the Minute Volume (MV), the patient will be instructed to inhale and exhale slowly for one minute and the value of MV and respiratory rate (RR) will be recorded. The respiratory rate was measured by the movements of the rib cage during respiratory cycles performed in one minute. The MV will be obtained by a Wright ® ventilometer (British Oxigen Company, London, England).

Respiratory rate12 to 24 hours after removal of drains and 24 hours after primary intervention

They will be assessed at baseline, immediately after and 10 minutes after each intervention. The respiratory rate was measured by the movements of the rib cage during respiratory cycles performed in one minute.

Heart rate12 to 24 hours after removal of drains and 24 hours after primary intervention

They will be assessed at baseline, immediately after and 10 minutes after each intervention, through multi-parameter monitor.

Peripheral Oxygen Saturation (SpO2)12 to 24 hours after removal of drains and 24 hours after primary intervention

They will be assessed at baseline, immediately after and 10 minutes after each intervention through the G-Tech® portable pulse oximeter.

Blood pressure12 to 24 hours after removal of drains and 24 hours after primary intervention

They will be assessed at baseline, immediately after and 10 minutes after each intervention. The blood pressure will be obtained through multi-parameter monitor.

Heart work measurement12 to 24 hours after removal of drains and 24 hours after primary intervention

They will be assessed at baseline, immediately after and 10 minutes after each intervention through the calculation of the double product (multiplication of systolic blood pressure by heart rate).

Thoracoabdominal mobility12 to 24 hours after removal of drains and 24 hours after primary intervention

Will be evaluated by thoracic and abdominal cirtometry

Painful perception in the surgical incision12 to 24 hours after removal of drains and 24 hours after primary intervention

Will be assessed at baseline, immediately after and 10 minutes after each intervention through a Visual Analog Scale, a one-dimensional instrument for evaluation of pain intensity, with a range of 1 to 10.

Degree of dyspnea12 to 24 hours after removal of drains and 24 hours after primary intervention

Will be assessed at baseline, immediately after and 10 minutes after each intervention, through the Modified Borg Scale, a vertical scale quantified from 0 to 10. Zero represents no symptoms and 10 represents maximum symptoms.

Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)12 to 24 hours after removal of drains and 24 hours after primary intervention

They will be assessed at baseline, immediately after and 10 minutes after each intervention, through clinical inspection.

Trial Locations

Locations (1)

Federal University of Santa Maria

🇧🇷

Santa Maria, Rio Grande Do Sul, Brazil

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